The Ethical Challenges of Human Research: Selected Essays

Hardcover | October 11, 2012

byFranklin G. Miller

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The use of human beings as research subjects poses distinctive ethical issues. Subjects of medical research are exposed to risks of harm for the sake of generating scientific knowledge that can benefit future patients and society. Ethical analysis of the challenges posed by research involvinghuman subjects requires careful attention to the contextual details of scientific experimentation. This book contains 22 essays by Franklin G. Miller on research ethics written over a 15-year period. With the exception of the first essay, all have been previously published in bioethics and medicaljournals. The book is arranged into four parts. Part One addresses a general ethical perspective on the protection of human subjects in clinical research, including paternalism in research regulation and acceptable limits to research risks. The essays in Part Two examine ethical issues in study design. Itincludes ethical analyses of controversial types of medical experimentation-studies that provoke psychiatric symptoms, induce infections, provide patients with placebos that withhold proven effective treatments or administer fake invasive procedures, test experimental treatments in cancer patientswho have exhausted all standard treatment options, and employ the use of deception to generate scientifically valid data. Part Three offers a systematic critique of "the therapeutic orientation" to clinical trials and the principle of clinical equipoise, which is widely regarded as a fundamentalnorm for randomized treatment studies. Part Four takes up a range of ethical issues relating to informed consent for research participation, including examination of "the therapeutic misconception" and presentation of a novel approach to the validity of consent: "the fair transaction model." Anabiding theme, developed in many of the essays is that the ethics of clinical research is importantly different from the ethics of medical care.

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The use of human beings as research subjects poses distinctive ethical issues. Subjects of medical research are exposed to risks of harm for the sake of generating scientific knowledge that can benefit future patients and society. Ethical analysis of the challenges posed by research involvinghuman subjects requires careful attention to...

Franklin G. Miller is a member of the senior faculty in the Department of Bioethics at the National Institutes of Health. He is co-editor of The Oxford textbook of Clinical Research Ethics, and The Ethics of Consent.

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Format:HardcoverDimensions:448 pages, 9.25 × 6.12 × 0.98 inPublished:October 11, 2012Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199896208

ISBN - 13:9780199896202

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Table of Contents

PrefaceAcknowledgmentsPart One: Protecting Human Subjects in Clinical Research: A General Perspective1. F. G. Miller: Situating research ethics: revisiting Beecher and Jonas2. F. G. Miller and A. Wertheimer: Facing up to paternalism in research ethics. Hastings Center Report 2007;37(3):24-343. F. G. Miller and S. Joffe: Limits to research risks. Journal of Medical Ethics 2009;35:445-449Part Two: Study Design4. F. G. Miller and D. L. Rosenstein: Psychiatric symptom-provoking studies: an ethical appraisal. Biological Psychiatry. 1997;42:403-95. F. G. Miller and C. Grady: The ethical challenge of infection-inducing challenge experiments. Clinical Infectious Diseases. 2001;33:1028-336. F. G. Miller: Placebo-controlled trials in psychiatric research: an ethical perspective. Biological Psychiatry. 2000;47:707-167. F. G. Miller and H. Brody: What makes placebo-controlled trials unethical? The American Journal of Bioethics. 2002;2(2):3-8. F. G. Miller, E. J. Emanuel, D. L. Rosenstein and S. E. Strauss: Ethical issues concerning research on complementary and alternative medicine. JAMA 2004;291:599-6049. F. G. Miller: Sham surgery: an ethical analysis. American Journal of Bioethics 2003;3(4):41-810. F. G. Miller and S. Joffe: Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option? Clinical Trials 2008;5:617-2311. F. G. Miller, D. Wendler and L. Swartzman: Deception in research on the placebo effect. PLoS Medicine 2005;2(9):e26212. F. G. Miller, J. P. Gluck and D. Wendler: Debriefing and accountability in deceptive research. Kennedy Institute of Ethics Journal 2008;18:235-51Part Three: Therapeutic Orientation and Equipoise13. F. G. Miller, D. L. Rosenstein and E. G. DeRenzo: Professional integrity in clinical research. Journal of the American Medical Association. 1998;280:1449-5414. F. G. Miller and D. L. Rosenstein: The therapeutic orientation to clinical trials. New England Journal of Medicine. 2003;348:1383-8615. F. G. Miller and H. Brody: A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. Hastings Center Report. 2003;33(3):19-2816. F. G. Miller and H. Brody: Clinical equipoise and the incoherence of research ethics. Journal of Medicine and Philosophy 2007;32:151-6517. F. G. Miller and S. Joffe: Equipoise and the randomized clinical trial dilemma. New England Journal of Medicine 2011;364:476-80Part Four: Consent18. F. G. Miller and S. Joffe: Evaluating the therapeutic misconception. Kennedy Institute of Ethics Journal 2006;16:353-6619. F. G. Miller and D. Wendler: Is it ethical to keep interim findings of randomized controlled trials confidential? Journal of Medical Ethics 2008;34:198-220. F. G. Miller: Research on medical records without informed consent, Journal of Law, Medicine and Ethics 2008;36:560-6621. F. G. Miller and S. D. Pearson: Coverage with evidence development: ethical issues and policy implications. Medical Care 2008;46:746-5722. F. G. Miller and A. Wertheimer: The fair transaction model of informed consent: an alternative to autonomous authorization, Kennedy Institute of Ethics Journal 2011;21:201-18